Insomnia Disorder Clinical Trial
Official title:
Mental Imagery and Targeted Memory Reactivation in Insomnia
In this clinical trial, the investigators test whether mental Imagery Rescripting (IR), a technique where the individual is instructed to transform a negative memory or image into a positive one, and olfactory Targeted Memory Reactivation (TMR), a technique used to strengthen memories, can reduce hyperarousal and insomnia severity in patients with Insomnia Disorder (ID). Patients with ID will be randomized into four groups: in the first group (SH group), patients will have 4 weekly sessions (1 session/week) of a minimal intervention for insomnia (sleep hygiene information) in the presence of an odorless diffuser, which will be also used during the night. In the second group (IR group), patients will use IR during wakefulness to induce a state of relaxation and positive emotionality. More specifically, during 4 weekly sessions of IR, patients will imagine a negative scenario related to their pre-sleep images or current concerns (e.g., social interactions, self-image, sleep problem, nightmares) and transform it into a positive script. They will then perform IR every day for 4 weeks at home in the presence of an odorless diffuser, which will be also used during the night. In the third group, patients will undergo the same 4 weekly IR sessions and an odor will be paired to the positive imagery and will be diffused during the night (TMR group). Patients from this group will also perform IR every day for 4 weeks at home. Finally, the fourth group (OA group) will receive 4 weekly sessions of sleep hygiene instructions in the presence of an odor, which will be also used during the night. Clinical evaluation of insomnia severity before and after the intervention will take place using the Insomnia Severity Index (ISI, primary outcome measure). At the end of these interventions, patients with persistent symptoms will benefit from an alternative experimental treatment ("rocking bed") in which they will be cradled for one night. The investigators hypothesize that patients treated with IR will have significantly reduced insomnia severity compared to participants who received a minimal intervention. They also hypothesize that patients of the TMR group, will have more reduced ID severity compared to participants performing IR and with an odorless diffuser, therefore without an association (IR group). Finally, they hypothesize that one night of sleeping in a rocking bed will improve objective measures of sleep in ID compared to a stationary condition.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | August 31, 2027 |
Est. primary completion date | May 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Age between 18 and 45 years - Insomnia disorder according to the International Classification of Diseases 3 (ICSD-3) - ISI > 10 - PSQI > 5 - No other current treatment for Insomnia Exclusion Criteria: - patients with another psychiatric disorder requiring acute treatment according to DSM-5 - patients with medical (e.g. neurological disorders) or other disorders explaining the predominant complaint of insomnia (e.g., sleep apneas with ODI>15/h, restless legs syndrome, periodic limb movements with PLM>15, chronic pain) - patients with significant substance use/withdrawal - patients with heavy smoking - known pregnancy - patients suffering from anosmia, olfactory related issues and respiratory pathology |
Country | Name | City | State |
---|---|---|---|
Switzerland | Center for Sleep Medicine | Geneva |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva | University of Geneva, Switzerland |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Temperament and Character Inventory | A 240-item self-administered questionnaire designed to measure 4 temperament and 3 character scales. | Baseline and 5 Weeks | |
Other | Pre-sleep Arousal Scale (PSAS) | A 16-item self-reported questionnaire designed to measure pre-sleep arousability, the score ranges from 16-80, 16 indicating no symptom severity and 80 indicating the higher symptom severity. | Baseline and 5 Weeks | |
Other | Arousal Predisposition Scale (APS) | A 12-item self-reported questionnaire designed to measure arousability | Baseline and 5 Weeks | |
Other | Digit Span Task | A working memory task, asking the participant to repeat a string of numbers which are displayed verbally, exactly as given, for "digits forward," and in reverse order for "digits backward" | Baseline and 5 Weeks | |
Other | Psychomotor Vigilance Task (PVT) | A sustained-attention, reaction-timed task that measures the speed with which subjects respond to a visual stimulus. | Baseline and 5 Weeks | |
Other | Declarative word paired-associate learning task | Subjects will be instructed to learn 46 word-pairs with an immediate (pre-sleep) and a delayed one (post-sleep) to assess overnight improvement | Baseline and 5 Weeks | |
Other | Attachment Style Questionnaire (ASQ) | A 40-item self-reported questionnaire designed to measure attachment style. | Baseline and 5 Weeks | |
Primary | Insomnia Severity Index (ISI) | Standardized questionnaire that measures ID severity, the score ranges from 0-28, zero indicating no symptom severity and 28 indicating the higher symptom severity. | Baseline, 5 Weeks and 3 Months | |
Secondary | Pittsburgh sleep quality index (PSQI) | Validated self-report scale to assess the quality of sleep, the score ranges from 0-21, zero indicating no symptom severity and 21 indicating the higher symptom severity. | Baseline, 5 Weeks and 3 Months | |
Secondary | Total Sleep Time (TST) | Time from sleep onset to sleep offset. This outcome is measured both subjectively and objectively. | Baseline and 5 Weeks | |
Secondary | Wake After Sleep Onset (WASO) | Number of awakenings during the night. This outcome is measured both subjectively and objectively. | Baseline and 5 Weeks | |
Secondary | Beck Depression Inventory II (BDI-II) | Validated self-report scale to assess depressive symptoms, the score ranges from 0-63, zero indicating no symptom severity and 63 indicating the higher symptom severity. | Baseline, 5 Weeks and 3 Months | |
Secondary | State Trait Anxiety Inventory (STAI) | Validated self-report scale to assess anxiety, the score ranges from 20-80, 20 indicating no symptom severity and 80 indicating the higher symptom severity. | Baseline, 5 Weeks and 3 Months | |
Secondary | Sleep efficiency (SE) | Ratio between total time spent in bed and total sleep time. This outcome is measured both subjectively and objectively. | Baseline and 5 Weeks | |
Secondary | Micro-arousals | Objective measure of micro-awakenings during the night. | Baseline and 5 Weeks |
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